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Completed Not applicable Interventional

A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy

ClinicalTrials.gov ID: NCT00664768

Public ClinicalTrials.gov record NCT00664768. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Randomized, DB Controlled Study to Evaluate the Nutritional Safety (Growth) of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow Milk Allergy, With or Without Other Food Allergies.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children from birth to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA. This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.

Study identification

NCT ID
NCT00664768
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Nutricia North America
Industry
Enrollment
126 participants

Conditions and interventions

Interventions

Dietary Supplement

Eligibility (public fields only)

Age range
1 Day to 8 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2008 (Type not available)
Primary completion
Jul 2012 (Actual)
Completion
Jul 2012 (Actual)
Last update posted
Dec 9, 2020

2008 – 2012

United States locations

U.S. sites
22
U.S. states
13
U.S. cities
21
Facility City State ZIP Site status
Pendleton Pediatrics Chandler Arizona 85224 —
Visions Clinical Research - Tucson Tucson Arizona 85712 —
Children's Investigational Research Program, LLC (CHIRP) Bentonville Arkansas 72712 —
Children's Hospital, LA Los Angeles California 90027 —
David Geffen School of Medicine at UCLA Los Angeles California 90095 —
Rosario B. Retino, MD, Inc Ontario California 91762 —
Choc Psf, Amc Orange California 92868 —
Nemours Children's Clinic Jacksonville Florida 32207 —
Alzein Pediatrics Evergreen Park Illinois 60805 —
Regional Research Specialists, LLC Shreveport Louisiana 71106 —
Craig A. Spiegel, M.D. Bridgeton Missouri 63044 —
Meridian Clinical Research, LLC Omaha Nebraska 68134 —
Weill Cornell Medical College New York New York 10021 —
Asheboro Research Associates Asheboro North Carolina 27203 —
Duke University Durham North Carolina 27710 —
Pediatrics, PLLC Holly Springs North Carolina 27540 —
John Panuto, M.D. Middleburg Heights Ohio 44130 —
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Childrens Hospital of Pittsburgh Pittsburgh Pennsylvania 15213 —
PI-Coor Clinical Research, LLC Burke Virginia 22015 —
Virginia Commonwealth University Richmond Virginia 23219 —
Advanced Pediatrics Vienna Virginia 22180 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00664768, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 9, 2020 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00664768 live on ClinicalTrials.gov.

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